Powered Driver

ABSTRACT

An apparatus and methods are provided to penetrate a bone and associated bone marrow using a powered driver having a gear assembly and a motor. The powered driver may include an indicator operable to show status of a power supply associated with the powered driver. The power supply may include a battery power pack having a diamond shaped cross section. The powered driver may have a handle with a corresponding cross section.

RELATED APPLICATION

This application is a continuation-in-part to patent applicationentitled “Apparatus and Method to Access To Bone Marrow”, Ser. No.10/449,476, filed May 30, 2003; a continuation-in-part to patentapplication entitled “Apparatus and Method to Access To Bone Marrow”,Ser. No. 11/253,959, filed Oct. 19, 2005; a continuation-in-part topatent application entitled “Apparatus and Method to Access To BoneMarrow”, Ser. No. 11/253,467, filed Oct. 19, 2005. This applicationclaims priority to U.S. Provisional Patent Application Ser. No.60/910,147, filed Apr. 4, 2007, and entitled “Powered Driver”. Thecontents of these applications are incorporated herein in their entiretyby this reference.

STATEMENT OF GOVERNMENT INTEREST

Embodiments of present invention were developed using funds providedunder United States Air Force contract number FA8650-06-C-6614. The U.S.government has certain rights in the invention.

TECHNICAL FIELD

The present disclosure is related to apparatus for penetrating a boneand associated bone marrow with a powered driver and inserting aintraosseous device into the bone marrow.

BACKGROUND OF THE DISCLOSURE

Every year, millions of patients are treated for life-threateningemergencies in the United States. Such emergencies include shock,trauma, cardiac arrest, drug overdoses, diabetic ketoacidosis,arrhythmias, burns, and status epilepticus just to name a few. Forexample, according to the American Heart Association, more than1,500,000 patients suffer from heart attacks (myocardial infarctions)every year, with over 500,000 of them dying from its devastatingcomplications.

Obtaining satisfactorily vascular access may be a critical problem inapproximately five (5%) percent to ten (10%) percent of patients treatedin either prehospital or hospital settings. In the U.S. approximatelysix million patients annually may experience problems with traditionalintravenous access. An essential element for treating medicalemergencies is rapid establishment of an intravenous (IV) line toadminister drugs and fluids directly into the circulatory system.Whether in an ambulance by paramedics, or in an emergency room byemergency specialists, the goal is the same—start an IV in order toadminister life-saving drugs and fluids. To a large degree, the abilityto successfully treat such critical emergencies is dependent on skilland luck of an operator in accomplishing vascular access.

While it is relatively easy to start an IV on many patients, doctors,nurses and paramedics often experience great difficulty establishing IVaccess in some patients. These patients are probed repeatedly with sharpneedles in an attempt to solve this problem and may require an invasiveprocedure to finally establish an intravenous route. A furthercomplicating factor in achieving IV access occurs “in the field” e.g. atthe scene of an accident or during ambulance transport where it isdifficult to see the target and excessive motion make accessing thevenous system very difficult.

In the case of patients with chronic disease or the elderly, theavailability of easily-accessible veins may be depleted. Other patientsmay have no available IV sites due to anatomical scarcity of peripheralveins, obesity, extreme dehydration or previous IV drug use. For thesepatients, finding a suitable site for administering lifesaving drugsbecomes a monumental and frustrating task. While morbidity and mortalitystatistics are not generally available, it is known that many patientswith life-threatening emergencies have died of ensuing complicationsbecause access to the vascular system with life-saving IV therapy wasdelayed or simply not possible. For such patients, an alternativeapproach is required.

Powered drivers associated with intraosseous (IO) devices typicallyinclude a housing with various types of motors and/or gear assembliesdisposed therein. A rotatable shaft may be disposed within the housingand connected with a gear assembly. Various types of fittings,connections, connectors and/or connector receptacles may be provided atone end of the rotatable shaft extending from the housing to releasablyengage an IO device with the powered driver. Examples of powered driversare shown in pending patent applications Ser. No. 10/449,503 filed May30, 2003 entitled “Apparatus and Method to Provide Emergency Access ToBone Marrow,” now U.S. Pat. No. ______; Ser. No. 10/449,476 filed May30, 2003 entitled “Apparatus and Method to Access Bone Marrow,” now U.S.Pat. No. ______; and Ser. No. 11/042,912 filed Jan. 25, 2005 entitled“Manual Intraosseous Device,” now U.S. Pat. No. ______.

SUMMARY OF THE DISCLOSURE

In accordance with teachings of the present disclosure, powered driversare provided for use in gaining rapid access to a patient's vascularsystem. One embodiment may include a powered driver operable to insertan intraosseous device into a patient's bone marrow at a selected targetsite. The powered driver may include a power supply operable to make atleast five hundred (500) insertions of an intraosseous device into boneand associated bone marrow. For some embodiments the associated powersupply may be operable to make over one thousand (1000) insertions. Forsome applications a powered driver incorporating teachings of thepresent disclosure may have the general configuration of a small pistol.

One embodiment of the present disclosure may include providing emergencyvascular access (EVA) by inserting a penetrator assembly into a bone andassociated bone marrow by means of a powered driver, detaching thepowered driver from the penetrator assembly, removing an innerpenetrator from an outer penetrator of the penetrator assembly andattaching an adapter suitable to communicate medications or fluids withthe bone marrow.

Another embodiment of the present disclosure may include manufacturing apowered driver, operable to penetrate bone and associated bone marrow,by forming a housing having a drive shaft extending from one end of thehousing. A connector may be formed on the one end of the drive shaft toreleasably attach a penetrator assembly to the drive shaft. A gearassembly may be disposed within the housing and rotatably engage withthe drive shaft. A motor may be disposed within the housing androtatably engaged to the gear assembly opposite from the drive shaft. Apower supply and associated electrical circuitry operable to power themotor may also be disposed within the housing.

Powered drivers incorporating various teachings of the presentdisclosure may be used to provide intraosseous access to a patient'svascular system in the sternum, the proximal humerus (the shoulderarea), the proximal tibia (below the knee) and the distal tibia (abovethe inside of the ankle).

A motor and gear assembly may be disposed within a housing and may beoperable to rotate the drive shaft at approximately twelve hundred(1200) revolutions per minute (RPM). The gear assembly may reducerotation speed of the motor by a ratio of approximately twenty to one(20:1). A trigger or on/off switch may extend from the housing. For someembodiments a five battery power pack may be disposed within thehousing. For other embodiments a four battery power pack may be disposedwithin the housing. Some embodiments may include an over current fuseoperational to reduce the chance of overheating of the batteries and/orpower pack.

For some embodiments a powered drive may include a housing having atrigger operable to activate a motor disposed within the housing. Aremovable trigger guard may be disposed over the trigger when thepowered driver is not in use. A lanyard may be used to securely engagethe removable trigger guard with the housing. The length of the lanyardmay be selected to accommodate placing the trigger guard over thetrigger to prevent accidental activation and removing the trigger guardfrom covering the trigger to allow activation of the motor.

For some embodiments a powered driver may be provided with a housinghaving a motor and a gear assembly disposed therein. Sound dampening maybe disposed within the housing to reduce noise associated with operationof the motor and gear assembly. A power supply status light may beprovide at a proximal end of the housing indicate if the battery poweris satisfactory (green light) or may be failing (red light). In oneembodiment, the light will remain green so long as there is more than10% of battery power remaining, once 90% of the battery power has beendrained the light will turn red.

Another aspect of the present disclosure may include forming a sealedhousing to prevent blood and/or other body fluids from contaminatinginterior portions of the housing and associated components such as thebattery, motor and/or reduction gear assembly. A trigger mechanism oroperating switch assembly may also be sealed with the housing to preventcontamination from blood and/or other fluids. Rubber or otherelastomeric material may be used to from a flexible, fluid seal over thetrigger mechanism or operating switch assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete and thorough understanding of the present embodimentsand advantages thereof may be acquired by referring to the followingdescription taken in conjunction with the accompanying drawings, inwhich like reference numbers indicate like features, and wherein:

FIG. 1A is a schematic drawing showing an isometric view of oneembodiment of a powered driver incorporating teachings of the presentdisclosure;

FIG. 1B is a schematic drawing showing a distal end view of the powereddriver of FIG. 1A;

FIG. 1C is a schematic drawing in section and in elevation taken alonglines 1C-1C OF FIG. 1B showing one example of a power supplyincorporating teachings of the present disclosure.

FIG. 1D is a schematic drawing in section showing one example of apowered drive having sound dampening materials in accordance withteachings of the present disclosure;

FIG. 1E is a schematic drawing taken along lines 1E-1E of FIG. 1Bshowing one example of a four battery power supply having a generallydiamond shaped cross section;

FIG. 2A is a schematic drawing showing an isometric view of a powereddrive including a trigger guard and a lanyard attached thereto inaccordance with teachings of the present disclosure;

FIG. 2B is a schematic drawing in section and in elevation showing apowered driver having a power source, a trigger, electrical circuits, amotor and a gear assembly incorporating various teachings of the presentdisclosure;

FIG. 2C is a schematic drawing showing a trigger guard in accordancewith teachings of the present disclosure;

FIG. 3 is a schematic drawing in section and in elevation with portionsbroken away showing another example of a powered drive having a housing,trigger assembly, motor, reduction gear and power source incorporatingteachings of the present disclosure;

FIG. 4A is a schematic drawing showing one example of an intraosseousneedle set or penetrator assembly which may be inserted into a patient'svascular system using a powered driver incorporating teachings of thepresent disclosure;

FIG. 4B is a schematic drawing showing an isometric view with portionsbroken away of a connector receptacle which may be releasably engagedwith a powered driver incorporating teachings of the present disclosure;

FIG. 5A is a schematic drawing in section with portions broken awayshowing one example of a protective cover in a first position blockingaccess to a trigger of a powered driver incorporating teachings of thepresent disclosure;

FIG. 5B is a schematic drawing showing the protective cover of FIG. 5Ain a second position allowing access to the trigger of the powereddriver;

FIG. 5C is an isometric drawing showing another example of a triggerguard in a first position blocking access to a trigger of a powereddriver incorporating teachings of the present disclosure; and

FIG. 5D is a schematic drawing showing the trigger guard of FIG. 5C in asecond position allowing access to the trigger of the powered driver.

DETAILED DESCRIPTION OF THE DISCLOSURE

Preferred embodiments of the disclosure and its advantages may be bestunderstood by reference to FIGS. 1A-5D wherein like numbers refer tosame and like parts. Vascular system access may be essential fortreatment of many serious diseases, chronic conditions and acuteemergency situations. Yet, many patients experience extreme difficultyobtaining effective treatment because of inability to obtain or maintainintravenous (IV) access. An intraosseous (IO) space provides a directconduit to a patent's vascular system and systemic circulation.Therefore, IO access is generally an effective route to administer awide variety of drugs, other medications and fluids equivalent to IVaccess. Rapid IO access or emergency vascular access (EVA) offers greatpromise for almost any serious emergency that requires vascular accessto administer life saving drugs, other medications and/or fluids whentraditional IV access is difficult or impossible.

Bone marrow typically includes blood, blood forming cells, andconnective tissue disposed in an intraosseous space or cavity surroundedby compact bone. Long bones such as the tibia typically have anelongated central cavity filled with yellow bone marrow and adipose orconnective tissue. Such cavities may also be referred to as a “medullarycavity”, “bone marrow cavity” and/or “intraosseous space.”

Compact bone disposed near an anterior or dorsal surface may be referredto as “anterior compact bone” or “anterior bone cortex.” Compact bonedisposed farther from the dorsal or anterior surface may be referred toas “posterior compact bone” or “posterior bone cortex.”

The upper tibia proximate a patient's knee or the humeral head proximatea patient's shoulder may be used as insertion sites for an IO device toestablish access with the patient's vascular system. Sternal access mayalso be used as an insertion site. Availability of multiple intraosseousinsertion sites and associated target areas in adjacent bone marrow haveproven to be especially important in applications such as emergencytreatment of battlefield casualties or other mass casualty situations.Teachings of the present disclosure may be used to obtain intraosseousaccess at a wide variety of insertion sites and target areas.

IO access may be used as a “bridge” for temporary fluid and/or drugtherapy during emergency conditions until conventional IV sites can befound and used. Conventional IV sites often become available becausefluids and/or medication provided via IO access may stabilize a patientand expand veins and other portions of a patient's vascular system. IOdevices and associated procedures incorporating teachings of the presentdisclosure may become standard care for administering medications andfluids in situations when IV access is difficult or not possible.

Intraosseous access may be used as a “routine” procedure with chronicconditions which substantially reduce or eliminate availability ofconventional IV sites. Examples of such chronic conditions may include,but are not limited to, dialysis patients, patients in intensive careunits and epilepsy patients. Intraosseous devices and associatedapparatus incorporating teachings of the present disclosure may bequickly and safely used to provide IO access to a patient's vascularsystem in difficult cases such as status epilepticus to give medicalpersonnel an opportunity to administer crucial medications and/orfluids. Further examples of such acute and chronic conditions are listednear the end of this written description.

Apparatus and methods incorporating teachings of the present disclosuremay include using a first IO needle set having a fifteen (15) gagecannula with a length of approximately fifteen (15) millimeters toestablish vascular access for patients weighing between approximatelythree (3) kilograms and thirty nine (39) kilograms. A second IO needleset having a fifteen (15) gage cannula with an approximate length oftwenty-five (25) millimeters may be used to establish vascular accessfor patients weighing forty (40) kilograms and greater.

The term “driver” may be used in this application to include any type ofpowered driver satisfactory for inserting an intraosseous (IO) devicesuch as a penetrator assembly, a catheter, an IO needle or an IO needleset into a selected portion of a patient's vascular system. Varioustechniques may be satisfactorily used to releasably engage or attach anIO device with a driver incorporating teachings of the presentdisclosure. A wide variety of connectors and associated connectorreceptacles, fittings and/or other types of connections with variousdimensions and configurations may be satisfactorily used to releasablyengage an IO device with a driver. A battery powered driverincorporating teachings of the present disclosure may be used to insertan intraosseous device into a selected target area in ten seconds orless. The reduced size and weight of drivers incorporating teachings ofthe present disclosure may accommodate use in emergency medical vehiclesand emergency crash carts at medical facilities and/or carrying inbackpacks of military personnel deployed for extended periods of time inremote locations.

The term “intraosseous (IO) device” may be used in this application toinclude any hollow needle, hollow drill bit, penetrator assembly, bonepenetrator, catheter, cannula, trocar, inner penetrator, outerpenetrator, IO needle or IO needle set operable to provide access to anintraosseous space or interior portions of a bone.

For some applications an IO needle or IO needle set may include aconnector with a trocar or stylet extending from a first one end of theconnector. A second end of the connector may be operable to bereleasably engaged with a powered driver incorporating teachings of thepresent disclosure. An IO needle or IO needle set may also include a hubwith a hollow cannula or catheter extending from a first end of the hub.A second end of the hub may include an opening sized to allow insertingthe trocar through the opening and the attached hollow cannula. Thesecond end of the hub may be operable to be releasably engaged with thefirst end of the connector. As previously noted, the second end of theconnector may be releasably engaged with a powered driver. A widevariety of connectors and hubs may be used with an IO deviceincorporating teaching of the present disclosure. The present disclosureis not limited to connector 180 or hub 200 as shown in FIGS. 4A and 4B.

Various features of the present disclosure may be described with respectto powered drivers 230 a-230 d, 330 a and 330 b (See FIG. 3). Variousfeatures of the present disclosure may also be described with respect tointraosseous device 160 such as shown in FIGS. 4A and 4B. However, thepresent disclosure is not limited to use with intraosseous device 160 orpowered drivers 230 a-230 d, 330 a and 330 b.

Powered driver 230 a as shown in FIGS. 1A, 1B, 1C, and 1E may besatisfactorily used to insert an intraosseous device at a desiredinsertion site adjacent to a bone and associated bone marrow. Powereddriver 230 a as shown in FIGS. 1A, 1B, 1C, and 1E may include one ormore features of the present disclosure. At least one or more featuresof the present disclosure may also be shown with respect to powereddrivers 230 b, 230 c, 230 d, 330 a, and 330 b (See FIG. 3).

Powered driver 230 a may include housing 232 having the generalconfiguration of a small pistol defined in part by handle 236. Variouscomponents associated with powered driver 230 a may be disposed withinhousing 232 including handle 236. For example a power source such asbattery pack 234 may be disposed within handle 236. Battery pack 234 mayhave various configurations and may include multiple batteries 238disposed within sealed packaging material 240 (See FIG. 1E). Forpurposes of describing various features of the present disclosure sealedpackaging material 240 is not shown in FIGS. 1C, 1D and 2A.

Handle 236 may be generally described as an elongated, hollow containersized to receive battery pack or power supply 234 therein. Housing 230 aincluding handle 236 may be formed from relatively strong, heavy dutypolymeric material. For some applications housing 232 may be formed intwo halves which are joined together to form a fluid tight seal with thevarious components associated with powered driver 230 a disposedtherein.

For such applications power source or power supply 234 may includedisposable batteries. In other embodiments, handle 236 may includeexterior connections configured to allow recharging of power supply 234.

Motor 244 and gear assembly 246 may be disposed within portions ofhousing 232 adjacent to handle 236. For embodiments represented bypowered drivers 230 a-e, respective motor 244 and gear assembly 246 maybe generally aligned with each other. Motor 244 may be rotatably engagedwith one end of gear assembly 246. Drive shaft 250 may be rotatablyengaged with and extend from another end of gear assembly 246 oppositefrom motor 244.

Distal end or first end 248 of housing 232 may include opening (notexpressly shown) with portions of drive shaft 250 extending therefrom.For some applications end 252 of drive shaft 250 extending from housing232 may have a generally pentagonal shaped cross section with taperedsurfaces 256 disposed thereon. Tapered surfaces 256 may be disposed atan angle of approximately three (3°) degrees with respect to alongitudinal axis or rotational axis (not expressly shown) associatedwith drive shaft 250. Relatively small magnet 257 disposed on theextreme end of drive shaft 250 opposite from distal end 248 of housing232. Fittings and/or connectors with various dimensions and/orconfigurations other than end 252 of drive shaft 250 and/or magnet 257may also be satisfactorily used with a powered driver incorporatingteachings of the present disclosure.

Intraosseous devices having corresponding tapered openings or connectorreceptacles may be releasably engaged with end 252 of drive shaft 250extending from housing 232. For example, end 252 extending from distalend 248 of housing 232 may be releasably engaged with tapered opening186 in connector 180 as shown in FIGS. 4A and 4B. Tapered opening 186and end 252 of drive shaft 250 preferably have non-sticking tapers.

For some applications both motor 244 and gear assembly 246 may havegenerally cylindrical configurations. Exterior portion 245 of motor 244may correspond with the largest outside diameter or nominal outsidediameter associated with motor 244. Exterior portion 247 of gearassembly 246 may correspond with the largest outside diameter or nominaloutside diameter associated with gear assembly 246. For embodiments ofthe present disclosure represented by powered drivers 230 a-230 b,exterior portion 245 of motor 244 may have a nominal outside diameterportion larger than any outside diameter portion associated with gearassembly 246.

Portions of housing 232 may have generally similar cylindricalconfigurations corresponding with exterior portions of motor 244 andgear assembly 246. For example, segment 232 a of housing 232 may have agenerally cylindrical, hollow configuration with an inside diametercompatible with exterior portion 245 of motor 244. Housing segment 232 bmay have a generally cylindrical, hollow configuration with an insidediameter compatible with exterior portion 247 of gear assembly 246.Since portions of motor 244 have an outside diameter that is larger thanthe outside diameter of any portion of gear assembly 246, housingsegment 32 a may have a larger outside diameter than the outsidediameter of housing segment 32 b.

Motors and gear assemblies satisfactory for use with a powered driverincorporating teachings of the present disclosure may be obtained fromvarious vendors. Such motor and gear assemblies are typically ordered as“sets” with one end of each motor securely attached to an adjacent endof an associated gear assembly. A drive shaft having various dimensionsand/or configurations may extend from the gear assembly opposite fromthe motor. The gear assemblies may sometimes be referred to as“reduction gears” or “planetary gears”. The dimensions and/orconfigurations of an associated housing may be modified to accommodatean associated motor and gear assembly.

For some applications a thrust pad structure 295 may be disposed betweenproximal end 249 of housing 232 and adjacent portions of motor 244. Thethrust pad structure 297 may also be disposed adjacent to distal end 248of housing 232. Thrust pad structures 295 and 297 may limit longitudinalmovement of motor 244, gear assembly 246 and drive shaft 250 withinassociated portions of housing 232. Thrust pad structures 295 and 297are also shown in FIGS. 1C and 1F. In some embodiments, thrust padstructure 295 may include one or more fixed portions of motor 244configured to locate motor 244 in relation to housing 232.

For embodiments represented by power driver 230 b as shown in FIG. 1Dsound damping material 296 may be disposed adjacent to proximal end 249of housing 232. One of the features of the present invention may includeplacing sound damping material at various locations within a housing toreduce noise associated with operating a powered driver while insertingan intraosseous device into a target area.

For embodiments of the present disclosure such as shown in FIG. 1Dpowered driver 230 b may include electronic circuit board or smart board274. Electrical circuit board 274 may also provide an electronic safetyswitch operable to turn off or deenergize motor 244 after power driver230 b has been energized for a selected amount of time. For example,electronic circuit board 274 may turn off power driver 230 b afterapproximately ten seconds. For other applications, electronic circuitboard 274 may turn off motor 244 after 20 seconds of operations. Thetime period for deenergizing motor 244 may be selected to save energy inan associated power source.

Powered drivers incorporating teaching of the present disclosure maytypically run only a few seconds during insertion of an intraosseousdevice into bone and associated bone marrow. Activation of an associatedmotor for a longer period of time may imply a malfunction or use of thepowered driver for other than normal IO insertion. To prevent drainingof batteries, the timeout or timing circuit may automatically turn offthe motor after a set time period such as ten (10) seconds or twenty(20) seconds. The time period may correspond with the length of timerequired to charge the capacitor shown in the above drawing. The timeoutor timing circuit may function as a battery saving device. The timeoutor timing circuit may be particularly important when a powered driver iscarried in a tool box or a backpack to prevent accident draining of thebattery.

Additional embodiments of the present disclosure are shown in FIGS. 2A,2B, and 2C. For such embodiments trigger guard 290 may be releasablydisposed over portions of trigger assembly 262 d extending from housing232 d. Trigger guard 290 as shown in FIG. 2A may be formed fromrelatively strong but flexible material. Trigger guard 290 may have agenerally U shaped configuration with ribs 292 formed on opposite sidesof trigger guard 290. When trigger guard 290 is disposed over end orbutton 264 d of trigger assembly 292 d, ribs 292 will preferably bedisposed immediately adjacent to portions of handle 236. A pair of ribs292 disposed on opposite sides of trigger guard 290 may be used toeasily release trigger guard 290 from covering trigger assembly 262 d.By placing respective ribs 292 on opposite sides of trigger guard 290,either the thumb (not expressly shown) of an operator's left hand orright hand may be used to remove trigger guard 290.

Another aspect of the present disclosure may include attaching a triggerguard with a housing using a lanyard. For example, lanyard 296 as shownin FIG. 2A may be formed from various types of flexible, light weightmaterial. First end 297 of lanyard 296 may be securely engaged with anappropriately sized opening formed in trigger guard 290. Second end 298of lanyard 296 may be securely engaged on the end of handle 236. As aresult of using lanyard 296, an operator may quickly release triggerguard 290 from power driver 230 c but will avoid losing trigger guard290.

As shown in FIG. 2A, power driver 230 c may also include electricalcircuit board 274 d operable to activate light 280. Powered drive 230 cas shown in FIGS. 1A-E, 2A-B, and 3 may include light 280 operable toindicate the status of power supply 240 d disposed within handle 236.Light 280 may be disposed at proximal end or second end 249 of powereddriver 230 c. For some applications light 280 may be activated whenbutton 264 of trigger assembly 262 is activated or depressed. A greenlight may be used to indicate that battery pack 234 b has sufficientpower to activate motor 244 and gear assembly 246. A red light may bevisible at indicator 280 to indicate that battery power 234 b may befailing. A wide variety of indicators including, but not limited to,light emitting diodes (LED's), liquid crystal displays (LCD's) and smallmore conventional light bulbs may be satisfactorily used with a powereddriver according to teachings of the present disclosure. In someembodiments, indicators may be covered by a user's hand when in use toavoid visibility (e.g., in some military situations).

Additional embodiments of the present disclosure are shown in FIGS. 3.For such embodiments a power supply 234 b may include five batteries238. The embodiment of the present disclosure as represented by powereddriver 230 c may also include one or more of the electronic circuitboards.

Penetrator assembly 160 as shown in FIGS. 4A and 4B may includeconnector 180, and associated hub 200, outer penetrator 210 and innerpenetrator 220. Penetrator assembly 160 may include an outer penetratorsuch as a cannula, hollow tube or hollow drill bit and an innerpenetrator such as a stylet or trocar. Various types of stylets and/ortrocars may be disposed within an outer penetrator. For someapplications outer penetrator or cannula 210 may be described as agenerally elongated tube sized to receive inner penetrator or stylet 220therein. Portions of inner penetrator 220 may be disposed withinlongitudinal passageway 184 extending through outer penetrator 210. Theoutside diameter of inner penetrator 220 and the inside diameter oflongitudinal passageway 184 may be selected such that inner penetrator220 may be slidably disposed within outer penetrator 210.

Metallic disc 170 may be disposed within opening 186 for use inreleasably attaching connector 180 with magnet 257 disposed on end 252of drive shaft 252. End 223 of inner penetrator 220 may be spaced frommetallic disc 170 with insulating or electrically nonconductive materialdisposed therebetween.

Tip 211 of outer penetrator 210 and/or tip 222 of inner penetrator 220may be operable to penetrate bone and associated bone marrow. Theconfiguration of tips 211 and/or 222 may be selected to penetrate a boneor other body cavities with minimal trauma. First end or tip 222 ofinner penetrator 220 may be trapezoid shaped and may include one or morecutting surfaces. In one embodiment outer penetrator 210 and innerpenetrator 220 may be ground together as one unit during an associatedmanufacturing process. Providing a matching fit allows respective tips211 and 222 to act as a single drilling unit which facilitates insertionand minimizes damage as portions of penetrator assembly 160 are insertedinto a bone and associated bone marrow. Outer penetrator 210 and/orinner penetrator 220 may be formed from stainless steel, titanium orother materials of suitable strength and durability to penetrate bone.

Hub 200 may be used to stabilize penetrator assembly 160 duringinsertion of an associated penetrator into a patient's skin, soft tissueand adjacent bone at a selected insertion site. First end 201 of hub 200may be operable for releasable engagement or attachment with associatedconnector 180. Second end 202 of hub 200 may have a size andconfiguration compatible with an associated insertion site for outerpenetrator 210. The combination of hub 200 with outer penetrator 210 maysometimes be referred to as a “penetrator set” or intraosseous needle.

Connector 180 and attached inner penetrator 220 may be releasablyengaged with each other by Luer type fittings, threaded connections orother suitable fittings formed on first end 201 of hub 200. Outerpenetrator 210 extends from second end 202 of hub 200.

For some applications connector 180 may be described as a generallycylindrical tube defined in part by first end 181 and second end 182.The exterior of connector 180 may include an enlarged tapered portionadjacent to end 181. A plurality of longitudinal ridges 190 may beformed on the exterior of connector 180 to allow an operator to graspassociated penetrator assembly 160 during attachment with a drive shaft.Longitudinal ridges 190 also allow connector 180 to be grasped fordisengagement from hub 200 when outer penetrator 210 has been insertedinto a bone and associated bone marrow.

Second end 182 of connector 180 may include opening 185 sized to receivefirst end 201 of hub 200 therein. Threads 188 may be formed in opening185 adjacent to second end 182 of connector 180. Threaded fitting 188may be used in releasably attaching connector 180 with threaded fitting208 adjacent to first end 201 of hub 200.

First end 201 of hub 200 may include a threaded connector 208 or othersuitable fittings formed on the exterior thereof. First end 201 may havea generally cylindrical pin type configuration compatible withreleasably engaging second end or box end 182 of connector 180.

For some applications end 202 of hub 200 may have the generalconfiguration of a flange. Angular slot or groove 204 sized to receiveone end of protective cover or needle cap 234 may be formed in end 202.Slot or groove 204 may be used to releasable engage a needle cover (notexpressly shown) with penetrator assembly 160.

For some applications a penetrator assembly may include only a single,hollow penetrator. For other applications a penetrator assembly mayinclude an outer penetrator such as a cannula, hollow needle or hollowdrill bit and an inner penetrator such as a stylet, trocar or otherremovable device disposed within the outer penetrator. Penetrator 210 isone example of a single, hollow penetrator or cannula.

The size of a penetrator may vary depending upon the intendedapplication for the associated penetrator assembly. Penetrators may berelatively small for pediatric patients, medium size for adults andlarge for oversize adults. By way of example, a penetrator may range inlength from five (5) mm to thirty (30) mm. The diameter of a penetratormay range from eighteen (18) gauge to ten (10) gauge. The length anddiameter of the penetrator used in a particular application may dependon the size of a bone to which the apparatus may be applied. Penetratorsmay be provided in a wide variety of configurations depending uponintended clinical purposes for insertion of the associated penetrator.For example, there may be one configuration for administering drugsand/or fluids to a patient's bone marrow and an alternativeconfiguration for sampling bone marrow and/or blood from a patient.Other configurations may be appropriate for bone and/or tissue biopsy.

For some applications connector 180 may be described as having agenerally cylindrical configuration defined in part by first end 181 andsecond end 182. Exterior portions of connector 180 may include anenlarged tapered portion adjacent to end 181. A plurality oflongitudinal ridges 190 may be formed on the exterior of connector 180to allow an operator to grasp associated penetrator assembly 160 duringattachment with a drive shaft. Longitudinal ridges 190 also allowconnector 180 to be grasped for disengagement from hub 200 when outerpenetrator 210 has been inserted into a bone and associated bone marrow.

First end 181 of connector of 180 may included opening 186 sized toreceive portions drive shaft 52 therein. A plurality of webs 136 mayextend radially outward from connector receptacle 186. Webs 136cooperate with each other to form a plurality of openings 138 adjacentto first end 181. Opening 186 and openings 138 cooperate with each otherto form portions of a connector receptacle operable to receiverespective portions of a connector (not expressly shown) therein.

FIG. 5A-5D show further examples of trigger guards which may be usedwith a powered driver in accordance with teachings of the presentdisclosure. Power drivers 330 a and 330 b may include cap 338 disposedon one end of handle 336. Cap 338 may be used to replace a power supply(not expressly shown) disposed within handle 336.

For some embodiments a trigger guard may be slidably disposed onportions of a handle adjacent to an associated trigger assembly. Forexample, FIG. 5A shows power driver 330 a with trigger guard 390 a inits first position covering portions of trigger assembly 362. In FIG.5B, trigger guard 390 a is shown in its second position which allowsaccess to trigger assembly 362 for operation of power driver 330 a. Forsuch embodiments, trigger guard 390 a may be described as having agenerally elongated configuration with a U shaped cross section. Theprofile of the U shaped cross section of trigger guard 390 a may beselected to correspond with adjacent portions of handle 336 and triggerassembly 362. The length of trigger guard 390 a may correspondapproximately to the length of adjacent portion of handle 336.

For embodiments represented by power driver 330 b as shown in FIG. 5Cand 5D, trigger guard 390 b may have a generally U shaped configurationsimilar to corresponding portions of trigger guard 390 a. However, thelength of trigger guard 390 b may be substantially less than the lengthof trigger guard 390 a. For embodiments such as shown in FIGS. 5C and5D, pivot pin 392 may be disposed between portions of trigger guard 390b and adjacent portions of handle 396. Pivot pin 392 may allowrotational movement of trigger guard 390 b from a first positionblocking access to trigger assembly 362 as shown in FIG. 5C and a secondposition allowing access to trigger assembly 362 as shown in FIG. 5D.

Examples of acute and chronic conditions which may be treated usingpowered drivers, intraosseous devices, and procedures incorporatingteachings of the present disclosure include, but are not limited to, thefollowing:

-   -   Anaphylaxis (epinephrine, steroids, antihistamines, fluids, and        life support)    -   Arrhythmia (anti-arrhythmics, electrolyte balance, life        support);    -   Burns (fluid replacement, antibiotics, morphine for pain        control);    -   Cardiac arrest (epinephrine, atropine, amiodarone, calcium,        xylocaine, magnesium);    -   Congestive heart failure (life support, diuretics, morphine,        nitroglycerin);    -   Dehydration (emergency port for life support, antibiotics,        blood, electrolytes);    -   Diabetic Ketoacidosis (life support, electrolyte control, fluid        replacement);    -   Dialysis (emergency port for life support, antibiotics, blood,        electrolytes);    -   Drug overdose (naloxone, life support, electrolyte correction);    -   Emphysema (life support, beta adrenergics, steroids);    -   Hemophiliacs (life support, blood, fibrin products, analgesics);    -   Osteomyelitis (antibiotics directly into the site of infection,        analgesics);    -   Pediatric applications (shock, dehydration, nutrition,        electrolyte correction);    -   Renal Failure (both acute and chronic kidney failure, inability        to purify blood);    -   Seizures (anti-seizure medications, life support, fluid        balance);    -   Shock (life support fluids, pressor agents, antibiotics,        steroids);    -   Sickle cell crisis (fluid, morphine for pain, blood,        antibiotics); and    -   Trauma (emergency port for life support fluids, antibiotics,        blood, electrolytes).

Although the present disclosure and its advantages have been describedin detail, it should be understood that various changes, substitutionsand alternations can be made herein without departing from the spiritand scope of the disclosure as defined by the following claims.

1. An apparatus operable to insert an intraosseous device into a boneand associated bone marrow comprising: a housing with a drive shaftextending from an opening in the housing; the drive shaft operable toreleasably engage the intraosseous device; a motor disposed within thehousing and rotatably engaged with the drive shaft; a power supply andassociated electrical circuit operable to power the motor; a gearassembly disposed between and rotatably engaged with the motor and thedrive shaft; the motor and the gear assembly having respective generallycylindrical configurations; and the gear assembly having a nominaloutside diameter portion smaller than a corresponding nominal outsidediameter portion of the motor.
 2. The apparatus of claim 1 wherein theintraosseous device further comprises: a penetrator assembly defined inpart by a generally hollow, elongated cannula; and a removable innertrocar slidably disposed within the cannula.
 3. The apparatus of claim 1further comprising: a trigger assembly having at least one portionextending from the housing; and the trigger assembly operable toactivate the motor to rotate the drive shaft.
 4. The apparatus of claim1 wherein the housing further comprises: a generally cylindrical portionwith a handle extending therefrom; the drive shaft extending from oneend of the generally cylindrical portion; and the power supply disposedwithin the handle.
 5. The apparatus of claim 1 wherein the power supplyfurther comprises four batteries disposed adjacent to each other in agenerally diamond shaped pattern.
 6. The apparatus of claim 1 whereinthe power supply further comprises: four batteries disposed adjacent toeach other in a generally diamond shaped pattern; and a fifth batterydisposed on one end of the four batteries.
 7. The apparatus of claim 1wherein the power supply comprises: a generally diamond shaped crosssection; and a plurality of batteries disposed within the diamond shapedcross section.
 8. The apparatus of claim 1 further comprising an overcurrent fuse operational to reduce the potential overheating of thebatteries.
 9. The apparatus of claim 1 further comprising: an on-offswitch assembly having at least one portion extending from the handle;and the on-off switch assembly operable to activate the motor to rotatethe drive shaft.
 10. The apparatus of claim 1 further comprising atrigger switch operable to turn the motor on and off.
 11. The apparatusof claim 1 further comprising a timing circuit which may automaticallyturn off the motor after a set period of time to prevent draining thebatteries.
 12. The apparatus of claim 1 further comprising: an indicatordisposed on the handle proximate a distal end of the housing; and theindicator operable to display the amount of power available in the powersupply.
 13. The apparatus of claim 1 further comprising an over currentfuse operational to reduce the potential overheating of the power pack.14. A powered driver operable to insert an intraosseous device into abone and associated bone marrow comprising: a housing having a driveshaft extending from an opening in the housing; the drive shaft operableto releasably engage the intraosseous device; a motor disposed withinthe housing and rotatably engaged with the drive shaft; the housingincluding a handle with a power supply disposed within the handle; thepower supply and associated electrical circuits operable to power themotor; a trigger extending from the handle; the trigger operable toactivate the motor to rotate the drive shaft; and a trigger guarddisposed over the trigger to prevent undesired activation of the motor.15. The powered driver of claim 11 further comprising a lanyard having afirst end attached to the trigger guard and a second end attached to thehandle.
 16. The powered driver of claim 11 further comprising the powersupply having a generally diamond shaped cross section.
 17. The powereddriver of claim 11 further comprising: the trigger guard operable to bereleased by contact from the right thumb when the powered driver is heldin the right hand of an operator; and the trigger guard operable to bereleased by contact from the left thumb when the powered driver is heldin the left hand of an operator.
 18. The powered driver of claim 11wherein the power supply further comprises five batteries.
 19. A powereddriver operable to insert an intraosseous device into a bone andassociated bone marrow comprising: a housing having one end of a driveshaft extending therefrom; the one end of the drive shaft operable toreleasably engage the intraosseous device; a motor disposed within thehousing and rotatably engaged with the drive shaft; a power supply andelectrical circuits operable to power the motor; a switch assemblyconnected to the electrical circuits; and the switch assembly operableto activate the motor to rotate the drive shaft.
 20. The powered driverof claim 16 wherein the power supply further comprises: lithiumbatteries disposed in a sealed battery pack; and the lithium batteriesoperable to deliver at least five hundred insertions of respectiveintraosseous devices without recharge or replacement of the powersupply.
 21. The powered driver of claim 16 wherein the power supplyfurther comprises: lithium batteries disposed in a sealed battery pack;and the lithium batteries operable to deliver at least one thousandinsertions of respective intraosseous devices without recharge orreplacement of the power supply.
 22. The powered driver of claim 16further comprising: a portion of the switch assembly extending from thehousing; and the switch assembly operable to move between a first, onposition and a second, off position.
 23. The powered driver of claim 16further comprising: a gear assembly disposed between and rotatablyengaged with the motor and the drive shaft; both the motor and the gearassembly having generally cylindrical configurations; and the gearassembly having a nominal cross section less than a correspondingnominal cross section of the motor.
 24. The powered driver of claim 16further comprising: a gear assembly disposed between and rotatablyengaged with the motor and the drive shaft; both the motor and the gearassembly having generally cylindrical configurations; and the motorhaving an outside diameter portion larger than any outside diameterportion of the gear assembly.
 25. (canceled)